Actively Recruiting

Age: 0Years - 45Years
All Genders
NCT03911128

A Treatment Protocol for Participants 0-45 Years With Acute Lymphoblastic Leukaemia

Led by Mats Heyman · Updated on 2025-09-02

500

Participants Needed

53

Research Sites

717 weeks

Total Duration

On this page

Sponsors

M

Mats Heyman

Lead Sponsor

N

Nordic Society for Pediatric Hematology and Oncology

Collaborating Sponsor

AI-Summary

What this Trial Is About

The pilot study collects the experience of previously successful treatment of infants, children and young adults, with ALL from a number of well-renowned study groups into a new platform protocol, which is both a comprehensive system for stratification and treatment of ALL in this age-group as well as the basis for several randomised trials included in the study-design. The pilot study is implemented as a master protocol without study specific interventions, thus as an observational study. The pilot study is for countries/study-groups who intend to join ALLTogether1 (including experimental interventions). For these countries the pilot study is crucial to optimise diagnostics, registration systems, collaborations with vendors, logistics and data-checks before starting the main study. The study only includes "standard of care" treatment included in the master protocol.

CONDITIONS

Official Title

A Treatment Protocol for Participants 0-45 Years With Acute Lymphoblastic Leukaemia

Who Can Participate

Age: 0Years - 45Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients newly diagnosed with T-lymphoblastic or B-lymphoblastic precursor leukemia (ALL) confirmed by an accredited laboratory at a participating center
  • Age from 0 up to (but not including) 46 years at diagnosis
  • Patients with surface immunoglobulin negative BCP-ALL and IG::MYC rearrangement unless concurrent BCL2/6 rearrangement is present
  • Signed informed consent by patient or legal guardian as per country guidelines
  • Diagnosis and treatment at a participating pediatric oncology or adult hematology center
  • Resident or intending to settle permanently in a participating country
  • Women of childbearing potential must have a negative pregnancy test within 2 weeks prior to treatment start
Not Eligible

You will not qualify if you...

  • Patients younger than 1 year with KMT2A-rearranged BCP-ALL
  • Patients older than 45 years at diagnosis
  • Previous malignant diagnosis or relapse of ALL
  • Patients with mature B-ALL or IG::MYC with concurrent BCL2/6 rearrangement
  • Patients with Philadelphia chromosome-positive ALL
  • Known ALL prone syndromes except Down syndrome
  • Treatment with systemic corticosteroids (>10mg prednisolone/m2/day) for more than 1 week or chemotherapy within 4 weeks before diagnosis
  • Pre-existing contraindications to protocol treatment
  • Conditions interfering with study participation or compliance
  • Pregnant women of childbearing potential
  • Women breastfeeding
  • Fertile men and women unwilling to use adequate contraception during therapy
  • Essential diagnostic data missing at registration

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 53 locations

1

Aalborg University Hospital, Dept of Paediatrics

Aalborg, Denmark, 9000

Active, Not Recruiting

2

Aarhus University Hospital

Aarhus, Denmark, 8000

Active, Not Recruiting

3

Aarhus University Hospital, Child and Adolescent Health

Aarhus, Denmark, 8200

Active, Not Recruiting

4

Rigshospitalet, Dept of Haematology

Copenhagen, Denmark, 2100

Active, Not Recruiting

5

Rigshospitalet, Dept of Paediatrics

Copenhagen, Denmark, 2100

Active, Not Recruiting

6

Odense University Hospital, Dept of Paediatrics

Odense, Denmark, 5000

Active, Not Recruiting

7

North Estonia Medical Centre, Dept of Haematology

Tallinn, Estonia, 13419

Not Yet Recruiting

8

Tallinn Children´s Hospital, Dept of Paediatrics

Tallinn, Estonia, 13419

Not Yet Recruiting

9

Tartu University Hospital

Tartu, Estonia, 50406

Not Yet Recruiting

10

Helsinki University Hospital, Dept of Haematology

Helsinki, Finland, 00029

Active, Not Recruiting

11

Helsinki University Hospital, Dept of Paediatrics

Helsinki, Finland, 00029

Active, Not Recruiting

12

Kuopio University Hospital, Dept of Haematology

Kuopio, Finland, 70029

Active, Not Recruiting

13

Kuopio University Hospital, Dept of Paediatrics

Kuopio, Finland, 70029

Active, Not Recruiting

14

Oulu University Hospital, Dept of Haematology, Dept of Medicine

Oulu, Finland, 90029

Not Yet Recruiting

15

Oulu University Hospital, Dept of Paediatrics

Oulu, Finland, 90029

Active, Not Recruiting

16

Tampere University Hospital, Dept of Haematology

Tampere, Finland, 33521

Not Yet Recruiting

17

Tampere University Hospital, Dept of Paediatrics

Tampere, Finland, 33521

Active, Not Recruiting

18

Turku University Hospital, Clinical Haematology and Stem Cell Transplantation Unit

Turku, Finland, 20520

Not Yet Recruiting

19

Turku University Hospital, Dept of Paediatrics

Turku, Finland, 20520

Active, Not Recruiting

20

Landspitali University Hospital, Children's Hospital

Reykjavik, Iceland, 101

Active, Not Recruiting

21

Children's Hospital, Affiliate of Vilnius University Hospital

Vilnius, Lithuania, 08406

Active, Not Recruiting

22

Vilnius University Hospital

Vilnius, Lithuania, 08661

Active, Not Recruiting

23

Haukeland University Hospital, Dept of Haematology

Bergen, Norway, 5021

Active, Not Recruiting

24

Haukeland University Hospital, Dept of Paediatrics

Bergen, Norway, 5021

Active, Not Recruiting

25

Oslo University Hospital, Dept of Haematology

Oslo, Norway, 0372

Active, Not Recruiting

26

Oslo University Hospital, Dept of paediatric haemato- and oncology

Oslo, Norway, 0424

Active, Not Recruiting

27

Stavanger University Hospital, Dept of Haematology

Stavanger, Norway, 4011

Active, Not Recruiting

28

University Hospital North Norway, Dept of Haematology

Tromsø, Norway, 9019

Active, Not Recruiting

29

University Hospital of North Norway, Dept of Paediatrics

Tromsø, Norway, 9038

Active, Not Recruiting

30

St. Olavs University Hospital, Dept of Paediatrics

Trondheim, Norway, 7006

Active, Not Recruiting

31

St. Olavs University Hospital, Dept of Haematology

Trondheim, Norway, 7030

Active, Not Recruiting

32

Hospital Universitario de Cruces

Barakaldo, Spain

Actively Recruiting

33

Hospital Universitario San Joan de Déu

Barcelona, Spain

Actively Recruiting

34

Hospital Universitario Vall d'Hebron

Barcelona, Spain

Actively Recruiting

35

Hospital Universitario La Paz

Fuencarral-El Pardo, Spain

Actively Recruiting

36

Hospital Infantil Universitario Nino Jesus

Madrid, Spain

Actively Recruiting

37

Hospital Universitario Son Espases

Palma de Mallorca, Spain

Actively Recruiting

38

Hospital Universitario Virgen del Rocio

Seville, Spain

Actively Recruiting

39

Hospital Universitario Politécnico La Fe

Valencia, Spain

Actively Recruiting

40

Hospital Universitario Miguel Servet

Zaragoza, Spain

Actively Recruiting

41

Sahlgrenska University Hospital, Section for Haematology and coagulation

Gothenburg, Sweden, 41345

Active, Not Recruiting

42

Sahlgrenska University Hospital, Dept of Paediatric Haematology and Oncology

Gothenburg, Sweden, 41685

Active, Not Recruiting

43

Linköping University Hospital, Dept of Haematology

Linköping, Sweden, 58185

Active, Not Recruiting

44

Linköping University Hospital, Dept of Paediatrics

Linköping, Sweden, 58185

Active, Not Recruiting

45

Skåne University Hospital, Dept of Haematology

Lund, Sweden, 22185

Active, Not Recruiting

46

Skåne University Hospital, Dept of Paediatrics

Lund, Sweden, 22185

Active, Not Recruiting

47

Örebro University Hospital, Section for Haematology

Örebro, Sweden, 70185

Active, Not Recruiting

48

Karolinska University Hospital, Dept of Paediatric Oncology and Haematology

Stockholm, Sweden, 17176

Active, Not Recruiting

49

Karolinska University Hospital, Patient area Haematology

Stockholm, Sweden, 17176

Active, Not Recruiting

50

Norrland University Hospital, Dept of Haematology

Umeå, Sweden, 90185

Active, Not Recruiting

51

Norrland University Hospital, Dept of Paediatrics

Umeå, Sweden, 90185

Active, Not Recruiting

52

Uppsala University Hospital, Dept of Haematology

Uppsala, Sweden, 75185

Active, Not Recruiting

53

Uppsala University Hospital, Dept of Paediatric Haematology and Oncology

Uppsala, Sweden, 75185

Active, Not Recruiting

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Research Team

T

Trial Central Office

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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